A Phase Ib Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Heterologous Prime Boost Vaccination (ATP150/ATP152/ATP162, VSV-GP154) and Ezabenlimab (BI 754091) in Patients With Pancreatic Ductal Adenocarcinoma.
Study Identifier:
1515-0001
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
N/A
Recruitment Complete
Considering participating in a START clinical trial?
Study Summary
To Evaluate the Safety, Tolerability and Preliminary Efficacy of a Heterologous Prime Boost Vaccination (ATP150/ATP152/ATP162, VSV-GP154) and Ezabenlimab (BI 754091) in Patients With Pancreatic Ductal Adenocarcinoma.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I
Sex
Female & Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Recruitment Complete
Requirements information
Inclusion criteria
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC)
- ECOG performance status of 0 or 1.
- Patients with advanced or metastatic disease who completed at least 16 weeks of standard of care systemic chem-/chemoradiotherapy and achieved a partial response or stable disease.
- Patients who underwent confirmed R0 or R1 resection and completed at least 3 months of combined peri-adjuvant multiagent chemotherapy.
- No evidence of disease progression or recurrence.
- Start of study treatment within 12 weeks from the last curative treatment (resected PDAC).
- Patient must have completed 8-12 cycles of FOLFIRINOX or mFOLFIRINOX either as adjuvant, neoadjuvant, or perioperative (Part C)
- Life expectancy at least 12 months (resected PDAC), or at least 6 months (advanced/metastatic PDAC).
- Archival tumor tissue availability for central KRAS analysis and research.
Exclusion criteria
- Not yet recovered from surgery (resected PDAC).
- Gastro-intestinal bowel obstruction.
- Other malignancy within the last 3 years.
- Prior chemotherapy or targeted small molecule therapy within 14 (locally advanced/metastatic PDAC) or 28 (resected PDAC) days from initiation of study treatment.
- Prior radiotherapy within 14 days (advanced/metastatic PDAC). No prior radiotherapy. in resected PDAC
- Prior use of immunotherapeutic agents, including but not limited to checkpoint inhibitors or VSV-based agents.
- Diagnosis of immunodeficiency, and/or history of allogeneic organ transplant
- Chronic systemic treatment with steroids or other immunosuppressive medications.
- Active autoimmune disease requiring systemic treatment within the last 2 years.
- Chronic or concurrent active infectious disease requiring systemic antibodies, antifungal, or antiviral treatment
- Major (according to the Investigator's judgment) surgery within 12 weeks from initiation of study treatment
- Use of Tamoxifen within 1 month prior to start of study treatment
Clinical Study Information for Healthcare Providers
By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.
Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Drew Rasco
Status
Recruiting
Condition(s) Treated at Site
Pancreas